S0212: Phase IIb Randomized Study of Celecoxib in Patients With High-Grade Squamous Intraepithelial Lesions of the Cervix
- Compare the complete response rate in patients with high-grade squamous intraepithelial
lesions of the cervix treated with celecoxib vs placebo.
- Compare the toxicity of these drugs in these patients.
- Determine, preliminarily, the effect of celecoxib on cyclooxygenase-2 expression and
human papilloma virus expression in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to high-grade squamous intraepithelial lesion status (cervical
intraepithelial neoplasia [CIN] 2 vs CIN 3). Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive oral celecoxib twice daily for 1 month.
- Arm II: Patients receive oral placebo twice daily for 1 month. In both arms, treatment
repeats monthly for 3 courses in the absence of disease progression or unacceptable
toxicity. All patients then undergo loop electrosurgical excision procedure or cone
biopsy to determine response.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study within 1-2 years.
Primary Purpose: Treatment
William R. Robinson, MD
Harrington Cancer Center
United States: Federal Government